UCN-01 in Treating Patients With Advanced or Metastatic Kidney Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030888
First received: February 14, 2002
Last updated: January 3, 2014
Last verified: December 2003
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of UCN-01 in treating patients who have unresectable stage III or stage IV kidney cancer.


Condition Intervention Phase
Kidney Cancer
Drug: 7-hydroxystaurosporine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase 2 Study Of UCN-01 In Advanced Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2002
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of UCN-01, in terms of time to objective progression, in patients with stage IV or unresectable stage III renal cell carcinoma.
  • Determine the objective response rate in patients treated with this drug.

OUTLINE: Patients receive UCN-01 IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-61 patients will be accrued for this study within 15 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IV or unresectable stage III renal cell carcinoma

    • Metastatic disease must be amenable to biopsy or appropriate for nephrectomy before study therapy
  • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • No known prior or concurrent CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine normal OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No history of clinically significant coronary artery disease
  • No symptomatic cardiac dysfunction
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Pulmonary:

  • No symptomatic pulmonary dysfunction

Other:

  • No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01
  • No other uncontrolled concurrent illness
  • No active or ongoing infection
  • No known immune deficiency
  • No psychiatric illness or social situation that would preclude study compliance
  • No insulin-dependent diabetes mellitus
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No prior mediastinal radiation

Surgery:

  • See Disease Characteristics
  • At least 4 weeks since prior nephrectomy

Other:

  • No more than 2 prior systemic therapies for metastatic renal cell carcinoma
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030888

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Brian I. Rini, MD University of California, San Francisco
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00030888     History of Changes
Other Study ID Numbers: CDR0000069208, UCSF-NCI-5522, NCI-5522
Study First Received: February 14, 2002
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
7-hydroxystaurosporine
Staurosporine
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014